NABP e-News: June 11, 2009
Four Deaths, 162 Illnesses Linked to Contaminated Syringes
Four deaths and 162 illnesses nationwide have been linked to a contaminated lot of syringes made in a North Carolina plant called AM2PAT, the Chicago Tribune reported on June 7, 2009. Food and Drug Administration (FDA) investigated reports of particles floating in the pre-filled syringes and found that the plant had switched to an unreliable sterilization method, the Tribune reports. The plant was closed in January 2008. Following an indictment, AM2PAT President Dushyant Patel reportedly fled the country.
FDA Warns of Serious Liver Injury Associated with Anti-Thyroid Drug
FDA has issued a warning to health care professionals about the risk of serious liver injury associated with the use of the anti-thyroid drug propylthiouracil for the treatment of Graves' disease. FDA has identified an increased risk of liver injury with propylthiouracil when compared to an alternative treatment for this condition, methimazole. FDA has received reports of 32 cases of serious liver injury associated with the use of propylthiouracil from 1969 through 2008. Of the 22 adult cases, FDA identified 12 deaths and five liver transplants. Of the 10 pediatric cases, there was one death and six reports of liver transplant. More information is available in the June 3 FDA news release.
NCL Developing National Medication Adherence Campaign
The National Consumers League (NCL), a private, nonprofit advocacy group representing consumer interests on marketplace and workplace issues, is developing a national campaign to promote the importance of taking medications as instructed. In addition to this broad message, the campaign will include additional outreach efforts targeted toward patients with certain chronic conditions, such as diabetes and cardiovascular disease. NCL convened nearly 100 stakeholders in early 2009 to help refine an action plan for the development and execution of the campaign. In April NCL conducted a series of preliminary focus groups, including two patient groups and three practitioner groups, to explore many of the concepts and issues included in the initial plan. NCL plans to hold a second stakeholder meeting in early fall to further this initiative.
Five Additional Facilities Awarded VAWD Accreditation
NABP recently accredited five additional facilities through its Verified-Accredited Wholesale Distributors® (VAWD®) program, bringing the total number of accredited facilities to 342 as of June 5, 2009. A full listing of VAWD facilities is available under Accreditation Programs on the NABP Web site.
- Accredo Health Group, Inc provides specialized pharmacy and distribution services through agreements with biotechnology drug manufacturers relating to the treatment of patients with certain costly, chronic diseases. The company received accreditation for its Memphis, TN facility.
- AmerisourceBergen Drug Corporation received accreditation for its Salt Lake City, UT facility. This facility is licensed in 15 states but ships a full range of prescription products to Utah, Nevada, Wyoming, Montana, Idaho, and Oregon.
- Exel, Inc is a third-party logistics provider for the specialty dental supply company Dentsply. Only a few prescription drug products are handled at this facility. The company received accreditation for its Lancaster, PA facility.
- MedVantx, Inc, dba Ameripharm, Inc distributes automated dispensing kiosks and accompanying prescription drugs to primary care physicians’ offices. It currently has approximately 600 machines in 10 states. The company received accreditation for its Sioux Falls, SD facility.
- Walgreen Company received accreditation for its Moreno Valley, CA facility. This facility ships approximately 800 prescription product orders per day to Walgreen's pharmacies and clinics in California, Arizona, Nevada, Hawaii, and Utah.